Acesion Pharma, a Danish biotech company developing novel treatments for atrial fibrillation (AF), the most common cardiac arrhythmia, announced it has received approval to commence its first clinical study for its lead compound AP30663. The phase 1 study in healthy subjects will be conducted at the Centre for Human Drug Research (CHDR) in the Netherlands and is due to start in March 2018. Acesion also announces the appointment of internationally renowned AF experts as scientific advisors.

Atrial fibrillation is the most common cardiac arrhythmia, affecting at least 10 million people in the US and Europe and 30 million people worldwide. The incidence of AF increases with age and it is estimated that 5–10% of the population above the age of 70 have AF. It is a progressive disease that is associated with significant morbidity and a 5-fold increased risk of stroke. Existing drug therapies for AF, using other modes of action, have encountered major safety issues due to their effects on the ventricles, leading to life threatening pro-arrhythmia and/or depression of the myocardial function. In addition, their efficacy and/or tolerability has limited their use and there remains a significant need for developing better, safer and tolerable treatments.

Acesion is developing a portfolio of drugs addressing both acute and persistent AF. Acesion’s novel approach is based on inhibition of SK channels – ion channels present in the atria that play a role in regulating the cardiac rhythm. Blocking these ion channels with a functionally atrial selective drug helps avoid deleterious effects on the ventricles. Targeting the SK channels thereby constitutes a novel and promising approach for an effective treatment of AF with an expected higher safety and tolerability profile.

With the approval of the CTA, Acesion will start the Phase 1 study of AP30663 in March 2018 to determine the safety and tolerability profile of a single ascending dose in healthy subjects. AP30663 has successfully completed the preclinical development program demonstrating a good safety profile and efficacy in converting AF to a normal sinus rhythm.

Acesion has appointed a group of scientific advisors comprising world-renowned experts in atrial fibrillation, including: Prof John Camm, Professor of Clinical Cardiology at St George’s Hospital Medical School, University of London and Professor of Cardiology at Imperial College London Dr Jeremy Ruskin, Professor of Medicine at Harvard Medical School and Founder and Director Emeritus of the Cardiac Arrhythmia Service at Massachusetts General Hospital Prof Dobromir Dobrev, Professor at the Institute of Pharmacology at the Universitätsklinikum Essen, Germany Bob Humphries, pharmacologist with 30+ years of pharma experience (Fisons, Astra and AstraZeneca) as scientific and cross-functional project team leader.

Commenting on the news, Frans Wuite, CEO of Acesion Pharma said: “Atrial fibrillation affects a large global population where current treatments have safety and efficacy limitations. We are very pleased to receive CTA approval for our first in-man study for our lead candidate. This is an important milestone for Acesion in our path towards developing first-in-class treatments that offer a unique efficacy and safety profile for AF patients.

“Our world leading scientific advisors are a validation of Acesion’s approach and technology platform. Their knowledge and expertise will be invaluable as we progress our pipeline of promising new AF treatments through clinical development.”